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PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants

Primary Purpose

Healthy, Trigeminal Neuralgia

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

BIIB074

Placebo

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

Japanese or Caucasian.
Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
Must have a body mass index between 18 and 30 kg/m2, inclusive.

Key Exclusion Criteria:

Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.
Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part 1

Part 2

Arm Description

48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio

16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily [TID] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily [BID] in cohort 5 for 6 days and QD for 1 day

Outcomes

Primary Outcome Measures

Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )

Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)

Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)

Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)

Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)

Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)

Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)

Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)

Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax

Part 2: PK of BIIB074 repeated oral dose as assessed by tmax

Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)

Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)

Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2

Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)

Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)

Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)

Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC

Secondary Outcome Measures

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with clinically significant laboratory assessment abnormalities

Number of participants with clinically significant vital sign abnormalities

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Number of participants with clinically significant physical examinations abnormalities

Full Information

NCT ID

NCT02831517

First Posted

July 11, 2016

Last Updated

March 7, 2017

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02831517

Brief Title

PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants

Official Title

A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Trigeminal Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1

Arm Type

Experimental

Arm Description

48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio

Arm Title

Part 2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

BIIB074

Other Intervention Name(s)

CNV1014802

Intervention Description

Administered as specified in the treatment arm

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matched Placebo

Primary Outcome Measure Information:

Title

Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)

Time Frame

15 minutes prior to dosing up to 96 hours post dose

Title

Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax

Time Frame